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目的 :评价重组人白细胞介素 11(rhIL 11)促进化疗后肿瘤患者血小板增值的疗效和耐受性 .方法 :采用随机、自身交叉、空白对照方法 ,患者按入组顺序随机分入AB或BA组 .AB组即第一周期化疗后使用rhIL 11为治疗周期 (A周期 ) ,第二周期化疗后观察为空白对照 (B周期 ) .BA组与AB组相反 ,即第一周期化疗后观察为空白对照 (B周期 ) ,第二周期化疗后使用rhIL 11(A周期 ) .rhIL 11于化疗后 2 4h开始用药 ,2 5 μg·kg-1皮下注射 ,每日 1次 ,连续用药 14d或连续 2次检查血小板计数至≥ 30 0× 10 9·L-1时停药 .结果 :共入选 19例患者 ,BA组 2例因第 1周期化疗后疾病进展 ,中止化疗而剔除 ,17例可评价疗效和毒性反应 .经统计学分析 ,治疗周期和对照周期化疗前的血PLT均值无差异 ;rhIL 11可升高化疗后患者PLT数的绝对值 ,起效时间位于化疗后第 10日 ;缩短PLT下降时间、延长PLT回升时间 ;对白细胞没有影响 ;于化疗后第 18日血红蛋白降低 .治疗相关的不良反应主要为发热、乏力、恶心呕吐、局部疼痛、水肿、头痛头晕和肌肉骨痛 ,均为WHOⅠ～Ⅱ度毒性 .结论 :rhIL 11可升高化疗后患者PLT数的绝对值、缩短PLT下降时间、延长PLT回升时间 .耐受性良好 .
Objective: To evaluate the efficacy and tolerability of recombinant human interleukin 11 (rhIL 11) in the promotion of thrombocytopenia in patients with cancer after chemotherapy.Methods: Randomized, crossover and blank control methods were used to randomly divide patients into groups AB or BA Group A.AB group after the first cycle of chemotherapy using rhIL 11 for the treatment cycle (A cycle), the second cycle of chemotherapy was observed as a blank control (B cycle) .BA group and AB group, the first cycle after chemotherapy was observed The blank control (B cycle) and rhIL 11 (cycle A) after the second cycle chemotherapy.rhIL 11 began to be given at 24 hours after chemotherapy, subcutaneously at 25 μg · kg -1, once daily for 14 days or continuously The patients were discontinued after two cycles of platelet count up to ≥30 0 × 10 9 · L -1.Results: A total of 19 patients were enrolled in the study. Two patients in BA group were excluded from chemotherapy due to the disease progression after the first cycle of chemotherapy and 17 patients were evaluable Efficacy and toxicity.According to statistical analysis, there was no difference in mean PLT before and after chemotherapy; rhIL 11 could increase the absolute value of PLT in patients after chemotherapy, and the onset time was on the 10th day after chemotherapy; shortening PLT Fall time, extend PLT rise time; white blood cells , And hemoglobin decreased on the 18th day after chemotherapy.The adverse reactions associated with treatment were mainly fever, fatigue, nausea and vomiting, local pain, edema, headache, dizziness and muscular bone pain.Conclusion: Can increase the absolute value of PLT in patients after chemotherapy, shorten the PLT decline time, prolong the PLT rise time. Well tolerated.